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Entry 2020.12.14 06:00
According to the pharmaceutical and biological industry on the 11th, national pharmaceutical companies developing COVID-19 treatments are driving clinical trials with the goal of conditional approval in the first half of next year.
Among the candidates for COVID-19 treatment, GC Green Cross and Celltrion, developing corona19 blood treatment and antibody treatments, respectively. In particular, the GC Green Cross is amazing. With nearly 700 confirmed cases per day in Korea, the demand for plasma treatments increased and four additional approvals for treatment purposes were obtained from the Ministry of Food and Drug Safety.
GC Green Cross Corona 19 blood system drug is a treatment made by extracting immunogenic antibodies from cure plasma. It is mainly used in high-risk patients in the medical field. Efficacy was also tested. A 70-year-old patient, who had not made much progress even after receiving the antiviral drug remdesivir and the steroid dexamethasone after receiving the latest corona 19 confirmation, was diagnosed with a cure after administration of GC5131A. Currently, the quarantine has been released following the final negative decision.
Celltrion leads the way with GC Green Cross. With the goal of “conditional approval from the Ministry of Food and Drug Safety during this year,” it is promoting clinical trials for CT-P59, a treatment for the COVID-19 antibody. He is currently awaiting results after completing the global phase 2 clinical trial in 327 patients.
CT-P59 is a recombinant neutralizing antibody therapy. It is produced by culturing cells after inserting a gene for an antibody with a strong virus-neutralizing ability into the blood of a cure for Corona 19. It is characterized by the formation of antibodies in the body immediately after administration.
Celltrion plans to apply for a conditional permit in consultation with related institutions, such as the Ministry of Food and Drug Safety, when the results of the phase 2 clinical trials are published. Celltrion has already completed initial production of CT-P59 at its plant in Songdo production in preparation for conditional approval of the Ministry of Food and Drug Safety.
Good news for newcomers
Newcomers such as Daewoong Pharmaceutical and Chong Kun Dang are also providing good news regarding treatment development. In particular, Daewoong Pharmaceutical, which has several corona 19 treatment lines, has made a surprising move in recent years.
Starting in January next year, the company has set a goal of providing patients with a COVID-19 treatment based on chamostat (Hoystar tablet). It is a goal that arose from eliciting a significant response in an experiment conducted on a recent domestic patient with mild Corona19.
Daewoong Pharmaceutical confirmed the efficacy and safety of its treatment through a comparative experiment between Kaletra Tablet (a drug used as a treatment for AIDS and as a treatment for mild patients with COVID-19) and Hoystar Tablet. Daewoong Pharmaceutical states that the current phase 2 clinical trial has obtained similar results. The Hoystar tablet is planned to be developed as a first-line treatment that can be administered to people in close contact with Corona 19 patients, suspicious symptoms, and self-isolation.
In addition, Daewoong Pharmaceutical has applied for a phase 2 clinical trial plan of ‘DWRX2003’, a candidate substance for the treatment of COVID-19 with niclosamide component, from the Korea Food and Drug Administration. The application was made based on DWRX2003 efficacy data previously obtained by Daewoong Pharmaceutical in a non-clinical trial. The company has confirmed its strong antiviral and anti-inflammatory effects. Clinical trials of DWRX2003 in 200 mild and moderate patients are scheduled to begin by year-end. He is also preparing to apply for phase 2 clinical trials in the United States based on safety data for phase 1 clinical trials abroad.
Chong Kun Dang is also participating in phase 2 clinical trials for the treatment of COVID-19 in Russia. Recently, a positive result was also obtained from the phase 2 mid-term evaluation of the Russian Data Security Monitoring Committee (DSMB).
Chong Kun Dang said: “The result of an interim evaluation of the safety and efficacy of the phase 2 clinical trial of Napaveltan’s DSMB in Russia confirmed its usefulness and recommended continuing with the clinical trial.” Said. In January next year, he plans to apply for conditional permits in Korea. Chong Kun Dang is currently in consultation with the Ministry of Food and Drug Safety on the review and approval program related to clinical outcomes.
Meanwhile, in Korea, commercialization of therapeutic agents is expected to take place faster than vaccines. Earlier, President Moon Jae-in said at the ‘Corona Metropolitan Area 19 Emergency Verification Meeting’: “If the plan goes smoothly, we expect to be able to use the treatment first before the vaccine.” “We will spare no support so that it can be done as soon as possible.”
Reporter Kim Yeon-ji [email protected]
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